Medication info
Dapaenmet Sustained Release Tablet 10/500 mg (Dapagliflozin, Metformin)

Dapaenmet Sustained Release Tablet 10/500 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pink, double-convex, oval-shaped sustained release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP)*5], 30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202301905 · Approved 2023.06.21

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin per day. For initial use, a starting regimen of 5 mg/500 mg or 10 mg/500 mg once daily is recommended. To reduce gastrointestinal side effects from metformin, doses should be adjusted gradually. In patients with renal impairment, dosage should be adjusted according to eGFR levels.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes with difficulty in blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is administered to adult patients with type 2 diabetes along with dietary and exercise regimens to improve blood sugar control through the combination of dapagliflozin and metformin. It is particularly important to consult a specialist regarding the risk of cardiovascular events when using dapagliflozin in patients with cardiovascular disease or risk factors for cardiovascular disease who are not achieving adequate blood sugar control. This medication effectively assists in blood sugar control and is used in diabetes management.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin per day. For initial use, a starting regimen of 5 mg/500 mg or 10 mg/500 mg once daily is recommended. To reduce gastrointestinal side effects from metformin, doses should be adjusted gradually. In patients with renal impairment, dosage should be adjusted according to eGFR levels.

Precautions

This medication is used in the treatment of diabetes and helps in controlling blood sugar levels. Do not use this medication if there is impaired kidney function, dehydration, severe infection, or weakened cardiac function. Women who are pregnant or breastfeeding should not take this medication, nor should those with known allergy to the drug. This medication can rarely cause a serious condition called lactic acidosis, so if you experience sudden fatigue, muscle pain, difficulty breathing, or abdominal pain, consult a doctor immediately. Additionally, if used with insulin or other blood sugar-lowering agents, be cautious of symptoms of hypoglycemia and carefully monitor blood sugar levels. This medication can cause dehydration or low blood pressure, so especially elderly patients or those on diuretics should frequently check fluid status and blood pressure. Urinary infections or genital infections may arise, so seek prompt treatment if symptoms of infection occur. It is advisable to avoid alcohol consumption while on this medication, and it should be avoided in cases of impaired liver or kidney function. For surgeries or contrast imaging tests, discontinue this medication 48 hours prior to surgery, and resume only after confirming normal kidney function. This medication can lower vitamin B12 levels, so if taken long-term, regular monitoring of vitamin B12 levels is required. Special caution is required for children and the elderly, and renal function in the elderly should be frequently monitored. In case of overdose, seek immediate medical attention for proper treatment, and dialysis may be necessary depending on symptoms. This medication does not significantly affect driving or machine operation, but caution is advised as dizziness may occur. Finally, keep out of reach of children and store in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • acute kidney failure
  • lactic acidosis
  • cardiopulmonary disease
  • sepsis
  • severe allergic reactions
  • severe skin reactions
  • respiratory problems
  • liver abnormalities (jaundice)
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  • severe neurological symptoms
  • severe edema or urinary problems
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • renal impairment
  • perineal gangrene (Fournier's gangrene)
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • acute cholecystitis
  • atrial fibrillation

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), decreased fluid volume, dry mouth, dizziness, constipation, oral dryness, back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, increased hematocrit, initial rise in serum creatinine, increased blood urea, dyslipidemia, weight loss, upper abdominal pain, dyspepsia, abdominal pain

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, with a recommended storage temperature between 1 and 30 degrees Celsius (room temperature). Following these storage practices will help maintain the efficacy of the medication safely.

Appearance and packaging

Appearance

Pink, double-convex, oval-shaped sustained release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP)*5], 30 tablets/bottle, 200 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.